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US Federal regulators have increased their oversight in areas that use human tissue, in particular targeting companies that remove tissue for use in medical procedures. The UK has recently undertaken a comprehensive review of the existing law that surrounds human tissue as a result of inquiries that identified a need to improve current practice. The inquiries related to a misinterpretation of legislation that led to a distressing and unacceptable situation for relatives of children and adults whose bodies, or part of their bodies, were used without their consent, after their deaths. The Retained Organs Commission (ROC) made recommendations for changes to the existing law (Department of Health, 2001a). The Human Tissue Act 2004 (HT Act) was created and relates to England, Wales and Northern Ireland. A separate Act, the Human Tissue (Scottish) Act 2006, is in place in Scotland.
This review explores the events leading up to the creation of the HT Act with a brief overview of the key points, remit and impact of the HT Act. (Editor's Note: The term "remit" may be understood as scope or responsibilities.)
The events leading to the development of the Human Tissue Act in the UK
Two public inquiries at the Bristol Royal Infirmary and the Alder Hey Children's Hospital were the catalyst for the creation of the HT Act in the UK. Both inquiries highlighted issues of consent, retention, and use of human tissue obtained from people after their deaths. The Isaacs Report summarised the findings from both inquiries and highlighted the fact that after people had died it was commonplace to find storage and use of their organs and tissue without proper consent being obtained (Department of Health, 2001a, 2001b, 2003).
These events caused much distress to relatives who were often unaware that organs had been retained. There was an urgent need to address this with a legislative review of the existing law to ensure that guidance for good practice in the storage and use of human tissue was developed and implemented. This review also served to restore public confidence and ensure that tissue obtained with consent would still be available for research and teaching purposes.
A public consultation was undertaken by the government as part of an overall legislative review to address this lack of attention to policies and procedures outlined in the existing legislation. The report (Department of Health, 2001c) summarised the changes necessary to the legal and regulatory framework to reflect advances in good practice and provided a lessons-to-learn approach. This made it clear that living patients would be required to consent to the retention and use of their organs and tissue for particular purposes beyond their diagnosis and treatment. There would also be mandatory consent for removal, retention, and use of tissue from the deceased given either by these people while still alive; or, in the event that they died without expressing their wishes, given by someone nominated by or close to them (Department of Health, 2001c). The independent Retained Organs Commission (ROC) was set-up as a recommendation from the legislative review and provided advice to the Government about the changes needed in the law, based on two rounds of consultations carried out in 2002 and 2003.
Summary of the HT Act 2004
The HT Act repeals and replaces a number of previous pieces of legislation. It provides a framework for regulating the storage and use of human organs and tissue from the living; and the removal, storage, and use of tissue and organs from the deceased for specified health related purposes and public display. In response to the ROC recommendations, the HT Act makes consent the fundamental principle underpinning the lawful retention and use of body parts, organs, and tissue from the living or the deceased for specified health related purposes and public display. (Human Tissue Authority, Homepage, n.d.; Human Tissue Act, 2004). The Human Tissue Authority (HTA) was established on 1 April 2005 under the HT Act and regulates the following activities:
1. Carrying out of an anatomical examination;
2. Making of a post-mortem examination;
3. Removal of relevant material from a deceased person;
4. Storage of relevant material from a deceased person (other than for a specific ethically approved project);
5. Storage of anatomical specimens;
6. Storage of relevant material from a living person for research (other than for a specific ethically approved project) or for human application;
7. Public display of a body or material from a deceased person.
The HTA has two principal statutory functions. The first is to inform the public and the Secretary for Health about issues within their remit. The second is to license and inspect according to their regulatory remit. The HTA provides guidance in the form of Codes of Practice covering the following areas (Human Tissue Authority, Codes of Practice, n.d.):
Code 1: Consent;
Code 2: Donation of solid organs, tissue and cells for transplantation;
Code 3: Post mortem examination;
Code 4: Anatomical examination;
Code 5: Removal, storage and disposal of human organs and tissue;
Code 6: Donation of allogenic bone marrow, peripheral blood stem cells and donor lymphocytes for transplantation;
Code 7: Public display;
Code 8: Import and export of human bodies, body parts and tissue.
The European Union Tissue and Cells Directive (EUTCD) also sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissue and cells intended for human application (The Commission of the European Communities, 2006). This Directive applies to the whole of the UK.
What is considered relevant material under the HT Act?
In Section 53 of the HT Act, the term "relevant material" is defined as material, other than gametes, which consists of or includes human cells, except for embryos outside the human body, or hair and nails from the body of a living person (Human Tissue Authority, 2004). The Human Fertilisation and Embryology Authority is responsible for regulating the use of human reproductive cells, that is gametes and embryos.
Consent is the fundamental principle
The principle of consent is fundamental to the HT Act. The flow chart (Figure 1) highlights that consent is not required for material that had been collected prior to the implementation of the HT Act on the 1st September 2006.
The need for a licence
The flow diagram (Figure 2) clarifies that in most instances a licence will be required to work with human tissue. The compliance report encompasses detailed information about consent, governance and quality, premises, facilities and equipment, and disposal. This will be verified in an inspection by the regulatory authority.
The flow diagram details the exemptions from the licensing framework. One major area of exemption is a specific project that is running under a favourable opinion from the National Research Ethics Service (National Patient Safety Agency, 2007).
The role of a Designated Individual
Researchers working with tissue in the UK will be familiar with a new role that was created during the implementation of the I-IT Act. The Designated Individual (DI) is considered the gatekeeper of anyone using tissue that falls under the licensing remit of the HTA in one particular premise, more specifically within one postcode area.
Section 18 of the HT Act provides that it shall be the duty of the DI to secure:
1. That the other persons to whom the licence applies are suitable persons to participate in the carrying on of the licensed activity;
2. That suitable practices are used in the course of carrying on that activity; and,
3. That the conditions of the licence are complied with.
[FIGURE 1 OMITTED]
[FIGURE 2 OMITTED]
The DI will complete the compliance report for the HTA and will be the point of contact for the desk-based assessment and inspection visits. Responsibility for all areas of the licence will lie with the DI with a personal liability. The DI ensures the consent process, training, governance arrangements, adequate facilities for storage and disposal according to the HT Act (Human Tissue Authority, 2006).
The Licence Holder
A Licence Holder can be an individual with managerial links to an establishment or a corporate body such as a university or hospital trust. In practical terms this means that a bigger organisation might have a Licence Holder as well as one or more DIs (Human Tissue Authority, 2006).
Persons Designated
A Persons Designated (PD), in the terms of the HTA, is a person to whom the licence applies. The PD does not have legal duties comparable to those of the DI.
Implementation of the HT Act at Bristol University
A Human Tissue Working Group (HTWG) was set-up to oversee the institutional processes and procedures to ensure compliance with the requirements of the HT Act. A baseline audit of current tissue holdings was performed across the institution to establish holdings exempt from supplying evidence of consent. The group raises awareness about the new legislation that would have an impact at the heart of the research and teaching culture. All Dis are invited to the HTWG to discuss compliance issues, best practice, training needs, and record keeping. The group receives high-level support from the University and reports to an executive Council Committee.
In preparation for the HTA's programme of inspection, the University initiated its own internal audit schedule. Dis cross-audit each other's licensed premises in accordance with this rolling programme. The objectives of the internal audits are to ensure that the activities on the premises satisfy the HT Act and relevant Codes of Practice. The internal audit team will work in close collaboration with the DI and the HTWG to identify practices that should be changed or improved. Training needs and resource requirements will be identified.
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